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Sponsored by: |
National Institute on Drug Abuse (NIDA) |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00780702 |
This study will evaluate whether, compared to placebo, aripiprazole increases the time to relapse to cocaine use in abstinent polydrug users in methadone maintenance therapy. Based on a the results of studies with aripiprazole in a preclinical model of relapse, we hypothesize that aripiprazole will reduce relapse to cocaine use.
Condition | Intervention | Phase |
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Cocaine Dependence |
Drug: aripiprazole Drug: placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Aripiprazole for Prevention of Relapse to Cocaine Use in Methadone-Maintenance Patients |
Estimated Enrollment: | 275 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | September 2015 |
Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: aripiprazole
Participants receive aripiprazole (orally, up to 15 mg/day) plus standard methadone maintenance (daily oral methadone and weekly individual counseling).
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2: Placebo Comparator |
Drug: placebo
Participants receive identical capsules containing no active medication plus standard methadone maintenance (daily oral methadone and weekly individual counseling).
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Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kenzie Preston, PhD | 443-740-2326 | kpreston@intra.nida.nih.gov |
Contact: Kenzie Preston |
United States, Maryland | |
National Institute on Drug Abuse Intramural Research Program | Recruiting |
Baltimore, Maryland, United States, 21224 | |
Contact: Kenzie L. Preston, PhD 443-740-2326 kpreston@intra.nida.nih.gov | |
Principal Investigator: Kenzie L Preston, PhD |
Responsible Party: | National Institute on Drug Abuse Intramural Research Program ( Kenzie L. Preston, Ph.D., Principal Investigator ) |
Study ID Numbers: | NIDAIRP426 |
Study First Received: | October 27, 2008 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00780702 |
Health Authority: | United States: Federal Government |
Cocaine-Related Disorders Methadone Mental Disorders Substance-Related Disorders |
Disorders of Environmental Origin Aripiprazole Cocaine |
Tranquilizing Agents Therapeutic Uses Physiological Effects of Drugs Psychotropic Drugs |
Central Nervous System Depressants Antipsychotic Agents Central Nervous System Agents Pharmacologic Actions |